Takin` Care of Business

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From the Lab to the Marketplace

NIH SBIR/STTR Programs

Michael Huerta, PhD

Associate Director for Program Development

National Library of Medicine, NIH

NIH Regional Seminar

June 2011

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SBIR & STTR Purpose

Stimulate technological innovation

Commercialize innovative technologies

Stimulate small business & economic growth

Foster technology transfer between small business concerns and research institutions

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Achieving the Purpose

Through SBIR & STTR awards

To small businesses

Supporting research & development of commercializable, innovative technologies

Serving the mission & priority of the awarding unit (Institute or Center)

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Achieving the Purpose

Through SBIR & STTR awards

To small businesses

Supporting research & development of commercializable, innovative technologies

Serving the mission of the awarding unit

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SBIR & STTR Awards

Awards are funds to the small business from the federal government

– control levels vary

Grants

Cooperative Agreements

Contracts

Awards support specific R & D projects (not general business costs, infrastructure, etc.)

Awards do not require

Repayment or debt service

Equity or intellectual property forfeiture

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How much is awarded through

SBIR & STTR programs?

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How much is awarded through

SBIR & STTR programs?

$2.4 Billion in FY 2010

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How much is awarded through

SBIR & STTR programs?

$2.4 Billion in FY 2010

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How much is awarded through

SBIR & STTR programs?

$2.4 Billion in FY 2010

NIH SBIR: $616 M

NIH STTR: $ 74 M

Total: $690M

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How much is awarded through

SBIR & STTR programs?

$2.4 Billion in FY 2010

NIH SBIR: $616 M

NIH STTR: $ 74 M

Total: $690M

SBIR 2.5 %

STTR 0.3 %

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NIH SBIR & STTR Programs

Summary of Key Features

SBIR & STTR Programs

Single SBIR/STTR grant solicitation

Investigator-initiated research ideas

Special FOAs (see NIH

Guide for

Grants and Contracts)

Electronic Submission (grants only)

Awards always made to small business concern

External Peer Review

Option to request review group

Experts from Academia/Industry

5 Criteria: Significance, Approach,

PI(s), Innovation, Environment

Summary Statement for all applicants

Revise & resubmit once

Multiple Receipt Dates (Grants)

April 5, August 5, December 5

May 7, September 7, January 7 (AIDS)

Contracts: Early November

Gap Funding Programs

Phase IIB Competing Renewals

Ph I/Ph II Fast Track

Administrative Supplements

Budget and Project Period

– Guidelines

$100-150K/6 -12months (Ph I)

$750K-1M/2 yrs (Ph II)

Deviations permitted where scientifically appropriate (eg, FOAs)

Technical Assistance Programs

Technology Niche Assessment

Commercialization Assistance

Pipeline to Partnerships (P2P)

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SBIR and STTR:

Critical Differences

Research Partner

SBIR: Permits partnering

33% Phase I and 50% Phase II

PI Employment

SBIR: Primary employment

(>50%) must be with small business concern

STTR: Requires partnering with

Research Institution

Small business (40%) and U.S. research institution (30%)

STTR: PI may be employed by either research institution or small business concern

Multiple PD/PI allowable

– for

SBIR only one PI must be primarily employed by SBC

Award is always made to Small Business Concern

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NIH SBIR/STTR: 3-Phase Program

Per Congressional Guidelines

– FOAs Vary

PHASE I Feasibility Study

Budget Guide: $150K (SBIR) or $100K (STTR) Total Costs

Project Period: 6 months (SBIR) or 1 year (STTR)

PHASE II Full Research/R&D

$750K (STTR) or $1M (SBIR) over two years

PHASE IIB Competing Renewal/R&D

Clinical R&D; Complex Instrumentation/Tools to FDA

Many, but not all, ICs participate

Varies ~$1M/year; 3 years

PHASE III Commercialization

not

funded by gov’t

NIH is generally not the “customer”

Consider partnering and exit strategy early

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Phase IIB Competing Renewal Award

Purpose:

Peer-reviewed continuation of Phase II R & D for complex projects

Parameters:

Up to $1M/year for up to 3 years

Eligibility:

Must have Phase II award // contact program officer for eligibility

Participating ICs: NIA, NIAAA, NIAID, NICHD, NIDA,

NIDCD, NIDDK, NIGMS, NEI, NHLBI, NIMH, NINDS, and

NCRR

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Beyond the Guidelines

The duration and amount of the SBIR or STTR award may exceed the congressional guidelines

• As required by the project – contact program officer before submitting the application to find out what would be allowed

• As allowed by special funding opportunity announcements

(FOAs), for example PA-11-134, Lab to Marketplace:

Phase I

– up to $350,000 per year for up to two years

Phase II

– up to $600,000 per year for up to three years

Phase IIB

– up to $800,000 per year for up to three years

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Beyond the Guidelines

The duration and amount of the SBIR or STTR award may exceed the congressional guidelines

One project could be supported with

~ $6 million over 8 years (Ph I, II, & IIB)!

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Phase I Phase II

No-Cost Extension

Phase I / Phase II Fast Track

Administrative / Competitive

Supplements

Mind the Gap

Phase IIB Competing

Renewal Award

Mt. “FDA”

Phase III

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NIH Phase I/Phase II Fast-Track

Bridging the Phase I - II Funding Gap

SBIR/STTR Phase I + Phase II

7-9 months

(Simultaneous Submission and Concurrent Review)

Phase I Award

Completion of Phase I

Phase I Final Report Program Staff assess completion of specific aims and milestones

Go?

No Go?

Aims/Milestones

Met

Phase II award

Aims/Milestones

NOT Met

Phase II award

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Achieving the Purpose

Through SBIR & STTR awards

To small businesses

Supporting research & development of commercializable, innovative technologies

Serving the mission of the awarding unit

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Achieving the Purpose

Through SBIR & STTR awards

To small businesses

Supporting research & development of commercializable, innovative technologies

Serving the mission of the awarding unit

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SBIR/STTR Eligibility Criteria

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U.S.

small business organized for-profit

At least 51% U.S.- owned by individuals independently operated or and

, for SBIR, at least 51% owned and controlled by another (one) business concern that is at least 51% owned and controlled by one or more individuals

500 or fewer employees, including affiliates

SBIR: At least one PI primarily employed small business ( STTR: not stipulated) with the

STTR: Formal collaboration between small business and research institution

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More SBIR/STTR Eligibility

Checkpoints

STTR : Formal collaborative effort means:

Minimum 40% by small business

Minimum 30% by U.S. research institution

STTR : Intellectual Property Agreement Needed

Allocation of Rights in IP and Rights to Carry out

Follow-on R&D and Commercialization

SBIR/STTR : Applicant is Small Business Concern

SBIR/STTR : All of the work must be done in the US

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Additional Eligibility Issues

Eligibility is determined at

No appendices allowed in Phase I

The PD/PI is not time of award required to have a Ph.D.

The PD/PI is required to have expertise to oversee project scientifically and technically

Applications agencies may be submitted to for similar work different

Awards may not be accepted from different agencies for duplicative projects

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Achieving the Purpose

Through SBIR & STTR awards

To small businesses

Supporting research & development of commercializable, innovative technologies

Serving the mission of the awarding unit

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Achieving the Purpose

Through SBIR & STTR awards

To small businesses

Supporting research & development of commercializable, innovative technologies

Serving the mission & priority of the awarding unit (Institute or Center)

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National Institute on Aging

NIH Institutes and Centers (ICs)

Office of the Director http://www.nih.gov/icd

National Institute on Alcohol Abuse and Alcoholism

National Institute of Allergy and

Infectious Diseases

National Institute of Arthritis and

Musculoskeletal and Skin Diseases

National Cancer

Institute

National Institute of Child Health and Human

Development

National Institute on

Deafness and Other

Communication

Disorders

National Institute of Dental and

Craniofacial

Research

National Institute of Diabetes and

Digestive and

Kidney Diseases

National Institute on Drug Abuse

National Institute of Environmental

Health Sciences

National Eye

Institute

National Institute of General

Medical Sciences

National Heart,

Lung, and Blood

Institute

National Human

Genome Research

Institute

National Institute of Mental Health

National Institute of Neurological

Disorders and

Stroke

National Institute of Nursing Research

National Institute

On Minority Health and Health

Disparities

National Center for Complementary and Alternative

Medicine

Fogarty

International

Center

National Center for Research

Resources

National Library of Medicine

National Institute of Biomedical

Imaging and

Bioengineering

No funding authority

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NIH Institutes & Centers

SBIR & STTR Budget Allocations

FY 2010 SBIR/STTR

Budget Allocations to NIH ICs:

SBIR: $616 M

STTR:$ 74 M

Total: $690 M

NIGMS NIDDK

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Submitted grant applications get appropriate assignment

Applications received by CSR and assigned to:

A CSR (usually) study section for peer review

An IC for programmatic (funding) consideration

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Submitted grant applications get appropriate assignment

Applications received by CSR and assigned to:

A CSR (usually) study section for peer review

An IC for programmatic (funding) consideration

Appropriate, however, is not necessarily optimal

You can help determine optimal assignment

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Relationship between project and study section

Dozens of study sections with different

Areas of review responsibility

Expertise of peer reviewers

Overlap from one study section to another

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Relationship between project and study section

Dozens of study sections with different

Areas of review responsibility

Expertise of peer reviewers

Overlap from one study section to another

Each study section has unique scientific focus and each reviewer has unique perspective

Determine the best match for your project

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How to determine which study section is best for your project

Center for Scientific Review (CSR) web site:

Scientific focus of each study section

List of study sections with similar scientific foci

Roster of members of each study section

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How to determine which study section is best for your project

Center for Scientific Review (CSR) web site:

Scientific focus of each study section

List of study sections with similar scientific foci

Roster of members of each study section

If more than one seems great,

Communicate with scientific review officers of those study sections for further guidance

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Relationship between project and IC

Dozens of ICs with different

Missions

– purviews of responsibility

Priorities

– areas of special interest or emphasis

A project could match mission, but not priority!

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Relationship between project and IC

Dozens of ICs with different

Missions

– purviews of responsibility

Priorities

– areas of special interest or emphasis

A project could match mission, but not priority!

Technologies are often cross-cutting, e.g.:

Neuroimaging tool

– cancer or stroke

Microfluidic chamber

– deliver drug or growth factor

Context of grant application or test bed for proposed feasibility test may determine IC

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How to determine which IC is the best fit for your project

Web sites of ICs

List research priorities, strategic plans, etc.

Annual Omnibus Solicitation for SBIR and

STTR Grant Applications

ICs list specific research topics

Special FOAs

Clear indication of participating ICs’ interests

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How to determine which IC is the best fit for your project

Web sites of ICs

List research priorities, strategic plans, etc.

Annual Omnibus Solicitation for SBIR and

STTR Grant Applications

ICs list specific research topics

Special FOAs

Clear indication of participating ICs’ interests

After narrowing down list of possible ICs, talk to the program officer(s) about your specific idea

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Cover Letter - Follow up for optimal assignment

Request potential awarding component(s): NIH

Institutes/Centers

– refer to program officer communication as appropriate

Request SBIR/STTR study section

Indicate key areas of review expertise required

Indicate individual(s)/organization(s) in conflict

For resubmission, indicate review history

Justify

all the requests you make

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SBIR & STTR Purpose

Stimulate technological innovation

Commercialize innovative technologies

Stimulate small business & economic growth

Foster technology transfer between small business concerns and research institutions

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Achieving the Purpose

Through SBIR & STTR awards

To small businesses

Supporting research & development of commercializable, innovative technologies

Serving the mission & priority of the awarding unit (Institute or Center)

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Drilling Down

Further Information,

Details, and Tips

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Application & Review Process

Remember: First get registered in Grants.gov AND eRA Commons!

Small Business

Concern

Research idea

– then contact NIH

Submits

SBIR/STTR Grant

Application to NIH

Electronically

NIH Center for Scientific Review

Assign to IC and Study Section

Scientific Review Groups

Evaluate Scientific Merit

~2-3 months after submission

IC Advisory Council or Board

Concurs with Review

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Grantee Conducts

Research

~2-3 months after review

IC

Allocates

Funds

IC Staff Prepare funding Plan for IC Director

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Review Criteria

Overall Impact Score

Scored Review Criteria (score 1-9)

Significance (Real Problem/Commercial Potential)

Investigators (PI and team)

Innovation (New or Improved?)

Approach (Research Design, Feasible)

Environment (Facilities/Resources)

Additional Review Criteria (not scored individually)

Protection of Human Subjects

Inclusion of Women, Minorities & Children

Vertebrate Animals

Biohazards

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NIH SBIR/STTR Success Rates FY2010

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5

0

13,7

33,5

SBIR

15,6

34,8

FY2010 $690 M

SBIR/STTR

20,2

23,4

Phase I

Phase II

Fast-Track

STTR

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Keys to Success

Understand mission & priorities

IC Web sites, Omnibus Solicitation, FOAs

Propose innovative ideas with significance as well as scientific and technical merit

Give yourself ample time to prepare application

Contact NIH Staff to discuss:

Research idea early on

– program staff

Assignment issues

– program and review staff

Outcome of your review

– program staff

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NIH Technical Assistance Program

Helping Companies cross the “Valley of Death”

Niche Assessment Program

Mt. “FDA”

???

Program

Phase I Phase II Phase III

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Commercialization

Assistance

(Phase II awardees)

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Technical Assistance Programs

Understanding the “B” in SBIR

Niche Assessment

(Phase I awardees)

Identifies other uses of technology

Determines competitive advantages

Develops market entry strategy

“Menu” of technical assistance/training programs in:

•Strategic/business planning

•FDA requirements

•Technology valuation

•Manufacturing issues

•Patent and licensing issues

Helps build strategic alliances

Facilitates investor partnerships

Individualized mentoring/consulting

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Finding a Partner

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NIH Pipeline to Partnerships

• Showcases SBIR/STTR (Phase I and Phase II) technologies and NIH-licensed technologies

• Facilitates matchmaking between NIH

SBIR/STTR awardees and potential strategic partners and investors

• Searches by application category (diagnostics, therapeutic, tool, etc.) and/or disease

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NIH Pipeline to Partnerships (P2P)

SBIR/STTR awardees and

NIH licensees can showcase technologies in a virtual space for potential partners.

http://www.ott.nih.gov/p2p/index.aspx

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NIH Pipeline to Partnerships (P2P)

POTENTIAL PARTNERS / INVESTORS

Identifies technology of interest and contacts company

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Summary of NIH SBIR & STTR

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Investments in innovation & economic growth

Advance the NIH mission & human health

Support and validate small business R & D

Extraordinary latitude in awards

Extraordinary assistance from idea to market

Scientific aspects

Administrative aspects

Business aspects

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Eligibility Criteria

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Ownership:

US-owned, independently operated

Affiliations:

Research Institutions,

Foundations, Foreign “Parents”

Size:

500 employees maximum

Business Structure:

Inc, LLP, LLC, ...

Principal Investigator:

Employment

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Ownership And Affiliations

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Eligibility of wholly-owned subsidiary

Owners of the SBIR organization must be

"individuals" who are "citizens of, or permanent resident aliens in, the United

States."

The regulations nowhere provide that corporations or artificial entities may qualify as "individuals" who are U.S. citizens.

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Ownership And Affiliations

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Parent of wholly-owned subsidiary is

FOREIGN

Sum TOTAL of ALL employees

• more than 500

(parent + subsidiary)

Sharing of officers on

Board of Directors

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PD/PI Eligibility on SBIR

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PI must have primary employment with SBC (unless waiver is granted)

More than 50% of PI’s time spent in

employ of SBC

Primary employment with SBC precludes full-time employment at another organization

Eligibility is determined at the time of award

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STTR Eligibility Criteria

Applicant Organization

Research Institution Partner

Project Director/Principal Investigator

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STTR Applicant Organization

Small Business Concern is

ALWAYS

the applicant/awardee organization

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STTR Research Institution

Partner

Must establish formal collaborative relationship with SBC

Must perform minimum of 30% of the research/R&D (maximum 60%)

Non-profit organization owned and operated exclusively for scientific or educational purposes

Non-profit medical and surgical hospitals

 eligible as partner as long as these institutions are exclusively engaged in scientific research and/or application of scientific principles and techniques

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PD/PI Eligibility on STTR

PD/PI: Not required to be employed by SBC

PD/PI: Must commit 10% effort (minimum)

PD/PI at RI: Must establish contract between

RI and SBC describing PD/PI’s involvement

PD/PI’s “signature” on Face Page represents agreement to conforming to Solicitation requirements

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PD/PI Role on STTR

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BUDGET PAGE

PI must be on SBC or RI budget,

• but NOT BOTH

PI and co-PI must be paid at either SBC or RI, but NOT BOTH

PI oversees all research activities on behalf of

SBC

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PI Role on STTR

NIH requires documentation from original employer/RI confirming change in employment status (e.g., sabbatical) for duration of

SBIR/STTR project

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PI cannot serve as consultant on same project

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